Evaluation of combinations of bedaquiline, moxifloxacin,...

In the News

Muhas don is new IHI board member

Prof. Kaaya. Ifakara Health Institute (IHI) Board of Governors (BOG) has appointed Prof. Sylvia Kaaya member of the IHI Board of Trustees (BOT) effective Wednesday January 10, 2018. The appointment …

Marcel steps down from IHI boards

Prof. Marcel Tanner has stepped down as Ifakara Health Institute (IHI) member of the Board of Trustees (BOT) and Board of Governors (BOG) effective Wednesday January 10, 2018. The Former …

Recent Projects

Understanding and enhancing approaches to quality improvement in small and medium sized private facilities in sub-Saharan Africa

This is an evaluation study that IHI is conducting in collaboration with London school of hygiene and tropical medicine. The research takes place in the context of an innovative intervention …

Vaccine Delivery Costing Study

As countries drive towards achieving high and equitable coverage of life-saving vaccines, the availability of sustainable, equitable, and predictable financing for vaccine delivery is essential. Over the last two decades, …

A phase 2 Open‐Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug‐Sensitive or Multi Drug‐ Resistant, Smear‐Positive Pulmonary Tuberculosis.

NC005 is a multicenter phase 2 Open‐Label Partially Randomized Trial to evaluate the efficacy, safety and tolerability of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug‐Sensitive or Multi Drug‐ Resistant, Smear‐Positive Pulmonary Tuberculosis. The primary objective of the study is to assess the mycobactericidal activity of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide regimens during 8 weeks of treatment. IHI enrolled only drug sensitive TB participants, whereby 31 participants were enrolled. Participants were randomized to receive either bedaquilline 400mg (J) (loading dose/t.i.w.), Pa824 200mg (Pa) and Pyrazinamide 1500mg (Z); or J (200mg)PaZ; or HRZE. The HRZE treatment arm is included as a control for the drug‐sensitive treatments. Enrollment and follow up complemented in February 2016 and currently participants are on a six monthly telephonic survival follow up until early 2018.

Lead Scientists:

Frederick Haraka

Francis Mhimbira

Partners

Mbeya Medical Research Centre-NIMR
TB Alliance
Swiss Tropical and Public Health Insitute

Funders

Global Alliance for TB drug development (TB Alliance)

Projects Location

A PIXELBASE DESIGN
© Ifakara Health Institute (IHI), 2016